Peblin Tablet 80mg (Febuxostat)

Adult dosage

1. Adults Administer 40mg or 80mg once daily, regardless of meals. Because this medication acts very rapidly, recheck the serum uric acid level after 2 weeks. The treatment goal is to lower the serum uric acid level to below 6 mg/dL(357 μmol/L) and maintain it there. 2. Patients with renal impairment No dosage adjustment is necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medication have not been adequately evaluated in patients with severe renal impairment (creatinine clearance less than 30mL/min). 3. Patients with hepatic impairment No specific dosage adjustment is necessary in patients with mild to moderate hepatic impairment. Only limited information is available for patients with moderate hepatic impairment, and the efficacy and safety of this medication have not been studied in patients with severe hepatic impairment (Child Pugh class C).

This drug can increase cardiovascular mortality in patients with cardiovascular disease; thus, patients with a history of major cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should consider alternative treatments instead of this drug. It should not be used in patients who are allergic to the components or excipients of this drug, and in patients who are taking mercaptopurine or azathioprine. Patients with genetic conditions such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also not take this drug. Patients with liver disease or a history of liver disease should undergo regular liver function tests before taking this medication, and caution is required in patients with thyroid dysfunction. It should be administered cautiously to patients with ischemic heart disease, congestive heart failure, and organ transplant recipients, and especially in patients with rapidly elevated uric acid levels, adequate hydration and alkalinization of urine are required to reduce the risk of urinary stones. During treatment with this drug, side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, myalgia, and dyspnea may occur, and any symptoms should be immediately discussed with healthcare personnel. This drug should not be started during acute gout attacks, and to prevent exacerbation of gout, it is recommended to take non-steroidal anti-inflammatory drugs or colchicine for at least 6 months in conjunction. This medication may cause drowsiness, dizziness, or paresthesia, so caution should be exercised when engaging in activities such as driving or operating machinery. Concurrent use of this drug with mercaptopurine or azathioprine must be avoided, and caution is needed for long-term safety when combined with theophylline due to increased renal excretion metabolites. Pregnant or breastfeeding women are advised not to take this medication, and there is no experience using it in children and adolescents under 18 years of age. In case of overdose, there is no specific antidote, so symptomatic treatment and supportive care are necessary. Keep this medication out of reach of children and there are no special storage conditions required.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, shortness of breath, vomiting, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, melena, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, gait disorders, influenza-like symptoms, mass, pain, thirst, cholecystitis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, decreased appetite, appetite reduction, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, arthralgia, joint swelling, muscle cramp, muscle single contraction, muscle constriction, muscle weakness, musculoskeletal pain, muscle rigidity, taste alteration, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory dysfunction, cerebral infarction, somnolence, mental disorder, migraine, sensory disturbance, drowsiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attack, personality changes, hematuria, nephrolithiasis, increased urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, excessive sinus secretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin necrosis, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, itching, purpura, skin discoloration, pigmentation changes, skin lesions, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, decreased bicarbonate, increased sodium, abnormal EEG, increased glucose, increased cholesterol, increased triglycerides, increased amylase, increased potassium, increased thyroid-stimulating hormone, decreased platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea nitrogen ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urine output, decreased urine output, decreased lymphocyte count, decreased neutrophil count, increased leukocyte count, decreased leukocyte count, abnormal coagulation tests, increased low-density lipoprotein, prothrombin time prolongation, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reaction accompanied by systemic symptoms, fever, hematological disorders, kidney disorders, liver disorders, liver failure, jaundice, hepatic impairment, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, increased CPK, hearing loss, fever, abdominal pain, diarrhea, malignant lung neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, pruritic rash, hepatic coma, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, allergic rhinitis, foot fracture, peripheral artery occlusive disease

This drug should be stored in a tightly closed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Pale yellow to yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle